Daewoong wins first patent dispute in Belkyra after 2 years

The IPT, approves defensive confirmation trial for the scope of a right

It helps to develop 'DWJ211', a subcutaneous fat improvement injection in phase III clinical trials

Belkyra

Daewoong has passed the first gateway for the release of generic for Belkyra (Deoxycholic acid), which targets and eliminates fat cells under the chin.

 

Daewoong won the patent dispute that has been leading for two years with Allergan.

 

The IPT ( Intellectual Property Trial and Appeal Board) made a trial decision on the 19th at Daewoong Pharmaceutical's passive judgment on the scope of the right to claim Belkyra's formulation patent.

 

The patent dispute related to Belkyra was triggered in March 2018 when Daewoong Pharmaceutical filed an invalidation trial on the formulation patent.

 

Subsequently, in April, a trial to confirm the passive scope of rights was raised against the same patent.

 

The dispute lasted more than two years.

 

In this process, Allergan used a “time wasting” strategy through patent splitting.

 

In January, two new patents were registered by removing some of them from existing patents.

 

Daewoong Pharmaceutical also challenged each of the two split patents.

 

Penmix, a subsidiary of Kuhnil Pharmaceutical, joined here.

 

This trial is the conclusion of the passive judgment of the scope of rights raised in 2018.

 

The result of the invalidation trial filed in the same year has not yet been announced.

 

However, the Patent Judge has notified that the hearing will be closed in March, so it is expected that the result of this trial will be released soon.

 

According to the industry, Daewoong Pharmaceutical analyzed that it raised a dispute with the aim of 'preemptive defense for the development of its own products' rather than 'early launching generics through patent evasion' from the beginning.

 

Daewoong Pharmaceutical is currently developing a submandibular fat improvement injection under the name 'DWJ211'.

 

Since March of last year, it has entered a phase III clinical trial in 150 patients at Konkuk University Hospital and Chung-Ang University Hospital.

 

The indication is 'improvement of moderate and severe submandibular fat', which is the same as that of Belkyra.

 

When development is finished, Allergan may file a patent infringement lawsuit.

 

At this time, the trial is expected to be properly used for defense purposes.

 

Even if the development of DJW211 is torn down, Daewoong Pharmaceutical will be able to release generics after August 24, 2023.

 

Belkyra's patent expiration date is August 23, 2031, and the PMS expiration date is August 23, 2023.

 

However, the generic release date is delayed if Allergan appeals.

 

Belkyra is the only subcutaneous fat injection to be approved by the U.S.

 

Food and the FDA.

 

Belkyra’s indications include moderate to severe protrusions in adults or excessive submandibular fat improvement.

 

It was released in Korea in early 2018.

 

Belkyra contains Deoxycholic acid, a 100% chemical compound that is not derived from humans or animals.

 

Injection of this substance subcutaneously irreversibly destroys the fat cell membrane and causes new collagen production at the treatment site.